Vaccine · 2005
Immunogenicity of an investigational quadrivalent Neisseria meningitidis-diphtheria toxoid conjugate vaccine in 2-year old children.
Клиническое исследованиеСтатьяРандомизированное исследованиеПоддержка NIH: внешняя программаПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод в очереди
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Granoff Dan M, Morgan Amy, Welsch Jo Anne
Аннотация
BACKGROUND: One dose of a quadrivalent meningococcal conjugate (MC-4) vaccine elicits higher group C bactericidal responses in 2-year olds than a U.S.-licensed quadrivalent polysaccharide (MPS-4) vaccine [Granoff DM, Harris SL. Protective activity of group C anticapsular antibodies elicited in 2-year olds by an investigational quadrivalent Neisseria meningitidis-diptheria toxoid conjugate vaccine. Pediatr Infect Dis J, 2004;23:490-7].
OBJECTIVE: Assess immunogenicity and persistence of serum antibody to capsular groups A, Y and W-135 in 2-year old children immunized with MC-4 vaccine.
DESIGN: Measurement of antibody responses in sera from a multicenter randomized trial comparing MC-4 and MPS-4 vaccines.
RESULTS: At 1 month, the group A serum bactericidal GMT was higher in the MC-4 than the MPS-4 group (P < 0.001) but there were no significant differences at 6 months. At 6 months, the respective Y and W-135 GMTs were higher in the MC-4 group (P < 0.05) but there were no differences at 1 month. The higher W-135 bactericidal titers reflected higher antibody avidity in the MC-4 group (P < 0.0001) and avidity maturation between 1 and 6 months (P < 0.05). At 2-year post-vaccination, the proportion of MC-4 immunized children with bactericidal titers > or =1:4 (presumed to be protective) was 15.0% (group A), 32.5% (group Y) and 45% (group W-135), as compared with 2.5, 15.4 and 17.5%, respectively, in unvaccinated children (P < 0.01 for group W-135; P < 0.05 for group A, and P = 0.07 for Y).
CONCLUSIONS: One dose of the MC-4 vaccine in 2-year olds elicits higher A, Y and W-135 bactericidal titers than MPS-4 vaccine. Compared with unvaccinated children, serum antibody titers remain elevated for 2 years after MC-4 vaccination. However, many vaccinated children have titers <1:4 and may require a booster dose for sustained protection.
OBJECTIVE: Assess immunogenicity and persistence of serum antibody to capsular groups A, Y and W-135 in 2-year old children immunized with MC-4 vaccine.
DESIGN: Measurement of antibody responses in sera from a multicenter randomized trial comparing MC-4 and MPS-4 vaccines.
RESULTS: At 1 month, the group A serum bactericidal GMT was higher in the MC-4 than the MPS-4 group (P < 0.001) but there were no significant differences at 6 months. At 6 months, the respective Y and W-135 GMTs were higher in the MC-4 group (P < 0.05) but there were no differences at 1 month. The higher W-135 bactericidal titers reflected higher antibody avidity in the MC-4 group (P < 0.0001) and avidity maturation between 1 and 6 months (P < 0.05). At 2-year post-vaccination, the proportion of MC-4 immunized children with bactericidal titers > or =1:4 (presumed to be protective) was 15.0% (group A), 32.5% (group Y) and 45% (group W-135), as compared with 2.5, 15.4 and 17.5%, respectively, in unvaccinated children (P < 0.01 for group W-135; P < 0.05 for group A, and P = 0.07 for Y).
CONCLUSIONS: One dose of the MC-4 vaccine in 2-year olds elicits higher A, Y and W-135 bactericidal titers than MPS-4 vaccine. Compared with unvaccinated children, serum antibody titers remain elevated for 2 years after MC-4 vaccination. However, many vaccinated children have titers <1:4 and may require a booster dose for sustained protection.